The Effects of NVX-108 as a Radiation Sensitizer in Glioblastoma (GBM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02189109|
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : February 28, 2019
This clinical trial is testing the safety, tolerability and effectiveness of NVX-108 administered via intravenous infusion in combination with standard radiation and chemotherapy.
NVX-108 is being developed to increase the amount of oxygen delivered to tumors which is hoped to increase the effectiveness of radiation therapy.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Drug: NVX-108||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Dose-finding, Pharmacokinetic and Pharmacodynamic Study of NVX-108 Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma Multiforme|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||August 31, 2017|
|Actual Study Completion Date :||April 2018|
Experimental: Dose Escalation
NVX-108 (DDFP liquid emulsion) i.v. in conjunction with Radiation Treatment and Temozolimide. 0.05-0.35cc/kg.
0.2% emulsion administered i.v.
Other Name: Dodecafluoropentane
- Safety and Tolerability of NVX-108 in Combination with Radiation and Temozolomide Defined by no Drug related Adverse Events (AE) in No More than 1 Patient per Treatment Group [ Time Frame: 6 months ]Adverse Events are considered to be neurological and hemodynamic
- Progression Free Survival at 6 months [ Time Frame: 6 months ]
- Tumor Reduction Based on Gd-MRI [ Time Frame: 4 months ]First determination will be measured at 4 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189109
|Australia, New South Wales|
|St. Vincents Hospital Sydney|
|Darlinghurst, New South Wales, Australia, 2010|
|Australia, South Australia|
|Flinders Medical Centre|
|Adelaide, South Australia, Australia, 5042|
|Melbourne, Victoria, Australia, 3004|
|Melbourne, Victoria, Australia, 3121|
|Principal Investigator:||Jason Lickliter, MBBSPhDFRACP||Nucleus Network|